In the United States, commercially available individual solid oral drug dosage form units (“drug units”) are not conventionally separable and uniquely identifiable on a per unit basis. Instead, each individual drug unit is identified based on its conformity to a uniform standard established for each drug product, such that drug units for a given drug product are typically indistinguishable from each other.
Current drug product identification is, in part, governed by Title 21 of the Code of Federal Regulations, Section 206.10, which provides a mechanism for the routine identification of solid oral dosage form drug products. That is, no drug product in a solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless each of its drug units is clearly marked or imprinted with a “code imprint” that, in conjunction with the unit's size, shape, and color, permits the identification of the drug product and the manufacturer or distributor of the drug product. A code imprint can refer to any single letter or number or any combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or symbols, assigned by a drug firm to a specific drug product. Such code imprints are usually uniformly coarsely embossed, debossed, engraved, stamped, or printed with ink onto or into each unit of a particular drug product as part of, or after, the manufacturing process.
While standardizing drug product appearance and requiring that each unit of a particular drug product conforms to the same criteria assists identification of drug units by comparison to a pre-set type for drug products generally, such uniformity also facilitates drug counterfeiting and obstructs the tracking and authentication of individual drug units. Once a counterfeiter is able to passably replicate the appearance of a single drug unit, production of mass quantities of drug units of a particular counterfeit drug product can proceed relatively unhindered. Counterfeiting is also aided, for example, by the ready commercial availability of tablet and pill manufacturing equipment, well-known and openly published fabrication methods, and fabrication methods and parameters that may be easily derived from direct observation of the code imprint and drug unit.
Efforts to create separable and uniquely identifiable drug units and drug unit authentication systems have been made. For example, the use of bar codes, engravings, stamps, etc., has been proposed as a way to uniquely identify individual drug units. However, such proposals require surface-to-surface contact between a marking instrument and each drug unit to identify each unit. Such direct surface-to-surface contact is undesirable for several reasons including, but not limited to, insertion of additional, expensive, slowing, and/or complicating steps into the process of manufacture, possible interference with other uniform drug product features useful for general product identification, and/or compromising the surface integrity and/or stability of the drug unit. Further, such efforts typically require that the end user have some sort of non-human machine visual or optical scanning device or reader to ascertain the meaning of, and to track and authenticate, each marked drug unit. The need for and reliance on such non-human analytical tools elevates the cost associated with using such marks and restricts patients and/or other end users' access and ability to independently authenticate marks.